SOLTIVE TFL-PLSRecalls & reported problems

Summary

The FDA's MAUDE database contains 450 adverse event reports that list this exact device (DI 00821925044111), received between Mar 22, 2021 and Sep 30, 2026 — classified as 71 injuries, 379 malfunctions.

The most frequently reported specific device problem is “Fire” (75 reports).

6 FDA recall records name this device's identifier, 6 still open.

4 other recalls cover devices cleared under the same FDA submission (K242191); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Feb 27, 2026Open, Classified

   Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.

   Z-1694-2026 · Root cause: Process control · FDA record ↗

2. May 6, 2025Open, Classified

   Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.

   Z-1921-2025 · Root cause: Under Investigation by firm · FDA record ↗

3. Apr 4, 2025Open, Classified

   Preset treatment parameters are not consistently being used in accordance with the IFU.

   Z-1715-2025 · Root cause: Unknown/Undetermined by firm · FDA record ↗

4. Aug 13, 2024Open, Classified

   The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the patients anatomy.

   Z-0134-2025 · Root cause: Under Investigation by firm · FDA record ↗

5. May 31, 2024Open, Classified

   Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.

   Z-2504-2024 · Root cause: Device Design · FDA record ↗

6. Jan 29, 2024Open, Classified

   A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.

   Z-1385-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 450 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Decoupling

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946402 ↗
• MalfunctionSep 29, 2026Power Problem; No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935125 ↗
• MalfunctionSep 22, 2026Flare or Flash

  The customer reported laser fired, sparked, and appeared to ignite/burn during an unspecified procedure involving an Olympus Powered Laser Surgical Instrument. The customer suspected that the cause of the broken fiber tip was due to fluid invasion. There was no patient injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50855038 ↗
• MalfunctionSep 21, 2026Break

  The customer reported broken power cord during set up / Inspection for use involving an Olympus Powered Laser Surgical Instrument. There was no patient injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842003 ↗
• MalfunctionSep 16, 2026Damaged Thread

  It was reported that the power cord had three exposed wires and without housing on the Olympus SuperPulsed Laser System. The issue occurred during preparation for use. There were no reports of patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50790939 ↗
• MalfunctionSep 16, 2026Computer Software Problem

  It was reported that the logs for our kilojoules and watts are not matching the treatment log with the Olympus SuperPulsed Laser System. The issue occurred during a therapeutic Laser Lithotripsy procedure. The procedure was completed using a same device. There was no patient harm reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50789882 ↗
• MalfunctionAug 17, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50279699 ↗
• MalfunctionAug 17, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50279559 ↗
• MalfunctionJun 25, 2026Break

  THE CUSTOMER RETURNED THE GENERATOR TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE FIELD SERVICE ENGINEER IDENTIFIED THE DEVICE EMERGENCY STOP BUTTON HAD BROKEN OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 25623490 ↗
• MalfunctionJun 10, 2026Fire

  THE CUSTOMER REPORTED CAUGHT FIRE DURING AN UNSPECIFIED PROCEDURE INVOLVING AN OLYMPUS POWERED LASER SURGICAL INSTRUMENT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25458359 ↗
• MalfunctionJun 5, 2026Communication or Transmission Problem

  THE CUSTOMER RETURNED THE SUPERPULSED LASER SYSTEM TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE FIELD SERVICE ENGINEER (FSE), INDICATES THAT A SYSTEM ERROR 10 WAS FOUND. IT WAS DETERMINED THAT THE EMERGENCY STOP BUTTON NEEDED TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25408837 ↗
• MalfunctionJun 2, 2026Device Emits Odor; Unexpected Shutdown

  IT WAS REPORTED THAT THE SOLTIVE LASER SYSTEM SMELLED LIKE BURNING. THIS ISSUE WAS OBSERVED DURING PREPARATION FOR USE. DURING TESTING, THE UNIT WAS FOUND TO UNEXPECTEDLY SHUT DOWN DUE TO A FAULTY POWER SUPPLY. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25360960 ↗
• MalfunctionJun 2, 2026Overheating of Device

  IT WAS REPORTED THAT WHEN THE SOLTIVE LASER SYSTEM WAS PLUGGED IN, THE USER REPORTED IT SMELLED LIKE BURNING. THIS ISSUE WAS OBSERVED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25360400 ↗
• MalfunctionJun 1, 2026Electrical /Electronic Property Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUPERPULSED LASER SYSTEM POSITION SENSOR WAS FAULTY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25351808 ↗
• MalfunctionMay 29, 2026Detachment of Device or Device Component

  THE CUSTOMER RETURNED THE POWERED LASER SURGICAL INSTRUMENT, WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, MISSING BACK PANEL CAUTION LABEL WAS OBSERVED. THE INVESTIGATOR INDICATED THAT THE MOST LIKELY CAUSE OF THE MISSING BACK PANEL CAUTION LABEL WAS DUE TO COMPONENT FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25331330 ↗
• MalfunctionMay 22, 2026Computer Software Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUPERPULSED LASER SYSTEM EXHIBITED ERROR E139. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 25257447 ↗
• MalfunctionMay 18, 2026Break

  IT WAS REPORTED THE POWERED LASER SURGICAL INSTRUMENT EMERGENCY STOP SWITCH WAS BROKEN. THERE WAS A PROCEDURAL PROLONGATION OF LESS THAN 30 MINUTES DURING A THERAPEUTIC URETEROSCOPY UNDER SEDATION. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25203691 ↗
• MalfunctionMay 13, 2026Power Problem

  IT WAS REPORTED THE SUPERPULSED LASER SYSTEM WAS INTERMITTENTLY LOSING POWER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164966 ↗
• MalfunctionApr 30, 2026Low Audible Alarm

  IT WAS REPORTED THE GENERATORS BEEPING WAS MUFFLED. THE ISSUE OCCURRED DURING A THERAPUETIC UTEROSCOPY WHEREIN RESULTED IN AN UNSPECIFIED DELAY. IN TURN, THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25049541 ↗
• MalfunctionApr 24, 2026Unexpected Shutdown; Activation Problem

  IT WAS REPORTED THAT THE POWERED LASER SURGICAL INSTRUMENT SHUT DOWN DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24983880 ↗
• MalfunctionApr 23, 2026Melted

  IT WAS REPORTED THE POWERED LASER SURGICAL INSTRUMENT'S LASER FIBER WAS BURNED/MELTED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24971136 ↗
• MalfunctionApr 22, 2026Insufficient Cooling

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE POWERED LASER SURGICAL INSTRUMENT'S FAN WAS RUNNING HOT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24952567 ↗
• MalfunctionApr 20, 2026Flare or Flash

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE POWERED LASER SURGICAL INSTRUMENT CONTAINED A BURN MARK ON THE VENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24932942 ↗
• MalfunctionApr 20, 2026Device Markings/Labelling Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE POWERED LASER SURGICAL INSTRUMENT BACK PANEL CAUTION LABEL WAS MISSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24931876 ↗
• MalfunctionApr 20, 2026Overheating of Device

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE POWERED LASER SURGICAL INSTRUMENT HAD BURN MARKS ON REAR PANEL AND COULD SMELL BURNING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24929275 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K242191. One submission often covers many models, so check the product and lot details in each record.

• Z-1695-2026 · Feb 27, 2026 · Open, Classified
  Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Number: TFL-SLS containing TFL-CSLU Product Description: An el
• Z-1923-2025 · May 6, 2025 · Open, Classified
  Brand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable Laser Fibers Model/Catalog Number: TFL-FBX150R, TFL-FBX200R, TFL-FBX365R, TFL-FBX550R, TFL-FBX940R, TFL
• Z-1920-2025 · May 6, 2025 · Open, Classified
  Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Number: TFL-SLS, TFL-SLS-JA (Japan only); Product Description: SOLTIV
• Z-1922-2025 · May 6, 2025 · Open, Classified
  Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Model/Catalog Numbers: TFL-FBX150BS, TFL-FBX200BS, TFL-FBX150S, TFL-FBX200